InterMune Announces Presentation of Interim Findings of the First Clinical Experience of Infergen Plus Actimmune Combination Therapy in Hepatitis C Nonresponders
Tuesday December 16, 7:13 pm ET
BRISBANE, Calif., Dec. 16 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today the presentation of interim findings from an independent retrospective clinical analysis done in collaboration with the New Jersey Medical Liver Center evaluating the clinical use of Infergen® (interferon alfacon-1) plus Actimmune® (interferon gamma-1b) in combination for the treatment of chronic Hepatitis C nonresponders. The clinical analysis was presented today at the 5th biennial HepDART meeting.
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The results presented were a summary of a retrospective analysis conducted on 32 patients who had previously failed to show any significant reduction in viral load following 12 weeks of therapy with peg IFN-alpha 2 plus ribavirin. This subpopulation of nonresponders is typically referred to as nullresponders and is considered to be one of the most difficult patient populations to treat. During the course of their clinical care, these nonresponders are being administered Infergen daily (15 micrograms), and Actimmune three times weekly (50 micrograms), for 48 weeks; ribavirin is not part of the regimen. The use of these compounds in combination is not approved by the FDA.
After 12 weeks of therapy with Infergen and Actimmune, 38% of this nonresponder patient group had undetectable levels of virus in their blood. Further, 65% of the patients had at least a 2 log decline in viral load. No patients discontinued therapy. Five patients received growth factor therapy for reductions in absolute neutrophil counts, a recognized side effect of interferon therapy. Other side effects observed were consistent with Infergen and Actimmune therapy. While these data are encouraging, important data points on sustained virologic response have not yet been collected.
"Treatment options for peg IFN-alpha 2 plus ribavirin nonresponders are very limited," said Carroll Leevy M.D., Director of Clinical Affairs, The New Jersey Medical Liver Center and Sammy Davis Jr. National Liver Center, Newark, New Jersey. "The data from this patient experience are encouraging, and this combination therapy may offer hope to patients who do not respond to standard interferon plus ribavirin therapy."
The scientific rationale for use of combination therapy of interferon alfacon plus interferon gamma is based on a number of observations. Scientific publications state that clearance of acute HCV infection requires a potent interferon gamma response. In addition, clearance of HCV in chronic patients treated with interferon-alpha requires activity that is mediated by interferon gamma. In InterMune labs, scientists analyzed the direct antiviral effects of Infergen and Actimmune in in vitro models. These models demonstrated very strong synergistic effects for a range of varying doses of combination therapy relative to Infergen monotherapy. Analysis of gene expression showed that several genes that undertake critical cellular processes were not significantly upregulated by either drug alone, but were upregulated by the combination of Infergen and Actimmune.
"These preliminary clinical findings are consistent with our demonstration of antiviral synergy upon co-administration of Infergen and Actimmune in in vitro models as presented at the American Association for the Study of Liver Disease Conference in October," said James E. Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. "While we await analysis of sustained virologic response, we are considering the initiation of an InterMune-sponsored clinical program using the combination of our two interferon products, Infergen and Actimmune, for the treatment of chronic Hepatitis C."
About Chronic Hepatitis C
According to the Centers for Disease Control an estimated 3.9 million (1.8%) Americans have been infected with HCV, of whom 2.7 million are chronically infected. Hepatitis C causes an estimated 10,000 to 12,000 deaths annually in the United States. The prevalence of chronic hepatitis C is increasing.
About Infergen® (interferon alfacon-1)
Infergen is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections and is dosed three times a week. Infergen is the only interferon alpha with data in the label regarding use in patients following relapse or non-response to treatment with certain previous treatments. The most common side effects are flu-like symptoms (i.e. headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile, by visiting www.infergen.com, including the black box warning for all interferon alphas regarding psychiatric, autoimmune, ischemic and infectious disorders.
About Actimmune® (interferon gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most commons side effects are flu-like symptoms, including fever, headache and chills. InterMune is also conducting a Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis, a Phase III study of interferon gamma-1b in ovarian cancer and a Phase II study of interferon gamma-1b in severe liver fibrosis, or cirrhosis, caused by hepatitis C virus (HCV). Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting www.actimmune.com. |
